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EMS ELECTRO MEDICAL SYSTEMS SA

⚠️ Moderate Risk

FEI: 3012388549 • Nyon, Vaud • SWITZERLAND

FEI

FEI Number

3012388549

📍

Location

Nyon, Vaud

🇨🇭
🏢

Address

Chemin De La Vuarpilliere 3, , Nyon, Vaud, Switzerland

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
1/23/2018
Latest Refusal
1/23/2018
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

24801×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

Refusal History

DateProductViolationsDivision
1/23/2018
76EFBHANDPIECE, AIR-POWERED, DENTAL
2480RXPERSONAL
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is EMS ELECTRO MEDICAL SYSTEMS SA's FDA import refusal history?

EMS ELECTRO MEDICAL SYSTEMS SA (FEI: 3012388549) has 1 FDA import refusal record(s) in our database, spanning from 1/23/2018 to 1/23/2018.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. EMS ELECTRO MEDICAL SYSTEMS SA's FEI number is 3012388549.

What types of violations has EMS ELECTRO MEDICAL SYSTEMS SA received?

EMS ELECTRO MEDICAL SYSTEMS SA has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about EMS ELECTRO MEDICAL SYSTEMS SA come from?

All FDA import refusal data for EMS ELECTRO MEDICAL SYSTEMS SA is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.